Skip to main content
OpenTrials
Completed

NCT Number: NCT02157181

Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.

CD20* = cluster of differentiation antigen 20

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hairy Cell Leukemia (HCL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Hairy Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Community based hemato-oncology medical office, Ansbach, Germany

Loading trial locations.

About this study

The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
  • Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
  • Need for treatment is indicated (see 4.3 below)
  • Age at least 18 years
  • General state of health according to WHO 0-2
  • Written declaration of consent by the patient
  • Current histology, which should not be older than 6 months, is necessary

Exclusion criteria

  • Patients, who do not fulfil the above-mentioned inclusion criteria.
  • Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50 mg/min
  • Patients with proven HIV infections
  • Patients with active hepatitis
  • Patients with other florid infections
  • Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
  • Pregnant or lactating women

Treatment and study plan

2CdA +/- Rituximab

Drug

Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Other names: Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg, Rituximab (Mabthera®; Rituxan®) 375 mg/m²

Primary outcomes

  1. Rate of complete remissions (CR)

    Time frame: 4 months after treatment

    Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab

    • in patients with hairy cell leukaemia variant
    • in patients with relapsed hairy cell leukaemia

Secondary outcomes

  1. Overall remission rate (ORR)

    Time frame: 4 months after treatment

    The rate of CR + PR will be determined

Other outcomes

  1. Acute and late toxicity

    Time frame: From day 1 of treatment period up to 120 months

    All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured

  2. Degree of induced immunodeficiency

    Time frame: From day 1 of treatment period up to 120 months

    Degree of immunosupression with CD4/CD8 quotient as indicating biomarker will be measured.

    Duration of immunosupression as well as infectious and other complications which result from therapy will be reported

  3. Frequency of secondary neoplasia during the life-long follow-up period

    Time frame: From day 1 of treatment period up to 120 months

    Rate of secondary neoplasia as safety issue will be determined

  4. Overall survival (OS)

    Time frame: From achieving a remission until death

    Determination of the overall survival times of all patients

Sponsors and collaborators

Lead sponsor

Jurgen Barth

Other

Registry information

Official study title

Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia

Important dates

Study start
2004
Primary completion
2012
Study completion
2013
First posted
Jun 5, 2014
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.